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The Tenex® 2nd Generation System is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of both soft and hard (e.g.: bone) tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery, and Plastic and Reconstructive Surgery.

The Tenex® 2nd Generation System is also indicated for use in the debridement of wounds, such as, but not limited to diabetic ulcers, in application, in which, in the physician's judgement would require the use of an ultrasonic aspirator with sharp debridement.

The Tenex 2nd generation system is an ultrasonic surgical instrument that fragments, emulsifies and aspirates soft and hard tissue. It also provides sharp debridement of soft and hard tissue in wounds such as neuropathic diabetic ulcers. The Tenex 2nd generation system is intended for use in an office-based setting, clinical or hospital environment. The system consists of a Console, ultrasonic MicroTips, a Foot Switch and a number of accessories.

The Console includes a touch screen tablet with a graphical user interface, motors to drive diaphragm pumps in the MicroTip, ultrasonic driver electronics and Software. The Console generates the ultrasonic energy required to operate the MicroTips and manages irrigation fluids. The Console is non-sterile when used and does not require processing.

The MicroTips connect to the Console for electrical power and to facilitate the transfer of irrigation fluid from the saline bag to the surgical site, and then aspirate the emulsified tissue and fluid to a collection bag incorporated into single use, disposable the MicroTip assembly. Motors in the Console couple to the diaphragm pumps in the MicroTips to control the fluid flows. The MicroTips are constructed from various biocompatible polymers and metals. The MicroTip tubing is made of biomedical grade PVC and silicone.

The MicroTips are single use and sterile packaged. They are sterilized via gamma irradiation. The MicroTips are the ultrasonic surgical hand pieces that house the transducers, horns and needles with beveled tips.

The Foot Switch is used by the user to remotely control the Console. It connects to the back of the Console via an electrical cable. It provides on/off functionality for cutting, irrigation, and aspiration. The Foot Switch is IPX8 rated for protection against liquids.

The System includes additional components. a Packaging Hard Case is provided for shipping, handling. and storage of the Console, and a power cord is provided for connecting the Console to facility electrical power to operate the device. These items are non-sterile when used and do not require processing.

Associated accessories include: a USB Flash Drive for saving procedure information, USBC-HDMI cable for connecting to an external display, and a USB-Smartphone adaptor for connecting USB output to a smartphone.

The provided text is a 510(k) summary for the Tenex® 2nd Generation System, an ultrasonic surgical instrument. It details the device's characteristics, intended use, and non-clinical performance testing. However, it does not include specific acceptance criteria or a study that directly proves the device meets those criteria in a format allowing a table of acceptance criteria vs. reported performance.

The document focuses on demonstrating substantial equivalence to a predicate device (Tenex Health TX System with the TXP MicroTip, K181367) through a comparison of technical characteristics and non-clinical performance testing against various standards.

Here's an attempt to extract and interpret the requested information based on the provided text, while noting what is not present:

Missing Information in the Provided Text:

• Specific Quantitative Acceptance Criteria: The document describes types of tests performed (e.g., Aspiration, Irrigation, MicroTip strength) and mentions the system "met requirements" or "met the standards," but it does not specify the quantitative performance metrics (e.g., "Aspiration volume must be >X cc/min" or "MicroTip strength must withstand Y force").
• Reported Device Performance against specific criteria: Without specific acceptance criteria, corresponding reported device performance against those criteria cannot be tabulated directly.
• Detailed Study Protocol for Performance Evaluation: The text lists various non-clinical performance tests but does not provide details of a single, comprehensive study with a defined sample size, ground truth, or expert involvement to "prove" the device meets acceptance criteria in a comparative sense.
• Sample size for test set with data provenance: While "simulated use testing in bovine tissue" and "simulated use testing in cadaver" are mentioned, the specific sample sizes for these tests are not provided. Data provenance is implied to be laboratory/simulated.
• Number of experts and qualifications for ground truth: Not mentioned, as the focus is on engineering and standard compliance rather than clinical interpretation.
• Adjudication method: Not applicable as no expert review process for ground truth is described.
• Multi Reader Multi Case (MRMC) comparative effectiveness study: Not mentioned and not likely relevant for a device of this type, which is a surgical instrument rather than an AI-powered diagnostic tool.
• Standalone (algorithm-only) performance: Not mentioned. The device's software is for control and interface, not for standalone diagnostic or analytical performance.
• Type of ground truth used: For the non-clinical tests, the "ground truth" would be the known physical properties and performance characteristics of the materials and systems under test, not clinical outcomes or pathology.
• Sample size for training set: Not applicable, as this is not an AI/ML device in the context of a training set for a diagnostic algorithm.
• How ground truth for training set was established: Not applicable.

Extracted Information (with caveats):

1. A table of acceptance criteria and the reported device performance

As noted, explicit quantitative acceptance criteria are not provided. The document states that the Tenex® 2nd Generation System "met all specified performance requirements" and "adheres to industry standards." The table below attempts to infer criteria based on the comparisons made with the predicate device and the non-clinical tests.

2. Sample sized used for the test set and the data provenance

• Sample Size: Not explicitly stated for any of the non-clinical tests (e.g., number of bovine tissue samples, number of cadavers, or number of units tested for electro-mechanical benchmarks).
• Data Provenance: The data originates from internal non-clinical performance testing conducted by the manufacturer (Trice Medical, Inc.), involving simulated environments (bovine tissue, cadaver) and laboratory bench tests. Implied to be prospective testing for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts/Qualifications: Not specified. For this type of device, ground truth for bench testing refers to engineering specifications and standard compliance, not clinical expert consensus. For usability testing (simulated use in cadaver), it implies evaluation by users (e.g., surgeons), but specific numbers or qualifications are not provided.

4. Adjudication method for the test set

• Adjudication method: Not applicable/not described as there isn't a stated panel review process for establishing ground truth in the context of this submission. The tests are against predefined engineering and regulatory standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically for diagnostic imaging software or AI tools, not for a surgical instrument.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: No, a standalone (algorithm only) performance study was not conducted. The software in the Tenex® 2nd Generation System operates the device and interfaces with the user, it does not perform an independent function that would require "standalone" performance evaluation in the context of diagnostic AI.

7. The type of ground truth used

• Type of Ground Truth: For the non-clinical performance tests, the "ground truth" is based on:
  • Engineering specifications and requirements: For electro-mechanical bench testing, software V&V.
  • International standards: For EMC, electrical safety, biocompatibility, sterilization, packaging, and shelf-life validation.
  • Expected physical and functional performance: For simulated use testing in bovine tissue and cadaver, validating that the device performs its intended functions (fragmentation, emulsification, aspiration) effectively and is usable.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This device is an electromechanical surgical instrument with controlling software, not an AI/ML diagnostic system that requires a "training set."

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.

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The mi-eye 3 needlescope™ with cannula, mi-eye tablet 3™ is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination of an interior cavity of the body through either a natural or surgical opening.

The mi-eye 3 needlescope™ with cannula, mi-tablet 3™ is a portable visualization device that uses a probe with integrated camera and separate LCD monitor attached via a cable. The sterile, single-use needlescope probe includes the camera and image capture features with LED light source. The mi-eye 3 probe connects to, and is powered by, the reusable mi-tablet 3. The mi-tablet 3 includes an internal battery and power supply, along with a cable for external charging. The mi-tablet 3 LCD Monitor displays a real-time image from the probe. The Monitor is also capable of connecting to separate ultrasound transducer, linear and convex, imaging probes and displaying their visual output. The mi-eye 3 needlescope™ with cannula has a rigid shaft that extends from the handle. The distal tip of the probe contains the camera, illumination, and imaging optics. Irrigation may be provided through the distal end of the probe from user supplied solution attached to the handle.

The mi-eye 3 needlescope™ with cannula is available in 75 and 95mm lengths with 0 and 25 degree viewing angles, relative to the axis of the probe is packaged with a scalpel, cannula, obturator and switching stick for use in creating and maintaining the channel for the probe. The monitor has a 12" (diagonal) screen. The probe weight is under 300 grams.

This document is a 510(k) summary for a medical device (mi-eye 3 needlescope™ with cannula, mi-tablet 3™). It asserts substantial equivalence to a predicate device and provides a table of performance data showing various tests passed. However, it does not contain the specific information required to answer your detailed questions about acceptance criteria for AI/ML device performance, the study design for proving it meets those criteria, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

The provided text describes a traditional medical device (an arthroscope and its associated monitor) and focuses on engineering and safety performance testing (e.g., biocompatibility, electrical safety, sterilization, mechanical strength). It is not an AI/ML powered device submission.

Therefore, based solely on the provided text, I cannot answer the questions about acceptance criteria and studies proving the device meets those criteria, as these pertain to AI/ML device performance, which is not discussed in this document.

The document details performance data related to manufacturing, safety, and physical properties (as seen in the "Performance Data" table), but these are not the type of performance criteria (e.g., sensitivity, specificity, AUC) you would expect for an AI/ML-powered diagnostic device.

If you have a different document or there's a misunderstanding of what "acceptance criteria" you are referring to based on the provided text, please clarify.

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The Camera Enabled Probe is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.

The Camera Enabled Probe is a battery operated, portable, visualization device that uses a probe with integrated camera and separate LCD monitor attached via cable. The sterile, single-use probe includes the camera and image capture features with LED light source. The LCD Monitor displays real-time video from the probe and is attached via cable to provide power to the probe. The probe scope extends from the handle as a rigid shaft with retractable needle and flushing port for cleaning the field of view. The distal tip of the probe contains the illumination and imaging optics. The Camera Enabled Probes are identical in design and function and available in three lengths: 50mm, 95mm, and 160mm. The monitor is 220mm X 135mm X 39mm. The entire unit weight is less than 300 grams.

The provided text describes a 510(k) premarket notification for a medical device called the "Camera Enabled Probe." The regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and testing against those criteria in a way that would be typical for an AI/ML device.

Therefore, the requested information elements related to AI/ML device performance (like specific performance metrics, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not present in the provided document. The document describes functional and safety testing to ensure the device meets predefined technical standards, which are different from a clinical performance study with statistical results against acceptance criteria for a diagnostic aid.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists industry standards that the device underwent testing against for functional and safety aspects. These are not performance metrics in the sense of accuracy, sensitivity, or specificity for a diagnostic output, but rather specifications for the device's physical and operational attributes.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified for any specific clinical performance test. The testing mentioned refers to "representative samples" for functional and safety testing.
• Data Provenance: Not applicable as no clinical performance study data is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as no clinical performance test with expert-established ground truth is described.

4. Adjudication method for the test set:

• Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No MRMC study was done. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No standalone algorithm performance study was done. This is not an AI device.

7. The type of ground truth used:

• Not applicable, as no clinical ground truth for diagnostic accuracy is presented. The "ground truth" for the functional and safety tests would be the specifications outlined in the respective standards.

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device and no training set is mentioned.

9. How the ground truth for the training set was established:

• Not applicable.

Overall Study Description:

The provided document describes a technical performance and safety assessment rather than a clinical performance study. The study presented focuses on ensuring the device (Camera Enabled Probe) meets established industry standards for:

• Biocompatibility (ISO 10993-1)
• Electrical safety and essential performance (IEC-60601-1)
• Electromagnetic compatibility (EN-60601-1-2)
• Sterilization validation (ISO-11135-1)
• Material specifications (ISO-9626, ISO-7864)

The conclusion states that Trice Medical, Inc. considers the Camera Enabled Probe to be equivalent to the predicate device (K093717 - C-MOR Visualization System) based on:

• Similarities in indications for use.
• Principles of operation.
• Technology.
• Materials.

This type of submission (510(k)) primarily demonstrates substantial equivalence to a legally marketed predicate device, often relying on non-clinical performance data and comparison to the predicate's technical specifications and safety profile, rather than a de novo clinical performance study against specific diagnostic acceptance criteria.

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